Company: Philips Medical Systems
Date of Enforcement Report: 11/10/04
Class: II
PRODUCT
Pagewriter Touch Cardiograph Software. Recall # Z-0063-05.
REASON
Software can generate printed ECG’s that associate incorrect patient data with the waveform.
CODE
Software Versions A.01.01 or A.01.02.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter on September 13, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
768 units.
DISTRIBUTION
Nationwide and Internationally.
